Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB)

The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES) by more than a prespecified amount. The study will enroll adults undergoing percutaneous coronary intervention (PCI) for a new coronary artery narrowing (de novo lesion). The main questions are: 1. Is fractional flow reserve (FFR) at 6 months noninferior after DCB-based PCI compared with DES-only PCI? FFR is a pressure-based measure used to assess blood flow through a coronary artery. 2. Does the DCB-based strategy reduce the number and total length of stents implanted? 3. What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up? Investigators will randomly assign 100 participants to one of two treatment strategies. In the DCB-based group, the lesion will first be prepared with a balloon. A DCB will be used if lesion preparation produces a suitable…

• Distal FFR at the target or culprit lesion

1. Study completion expected

   30 Sept 2029

2. Primary completion expected

   30 Sept 2028

3. Expected to start

   9 Nov 2026

4. Registered

   1 Oct 2026